Measurement of the amount of Amniotic Fluid (AF) volume is critical for assessing the kidney and lung function of a fetus and also for assessing the placental function of the mother. Amniotic fluid volume is also a key measure to diagnose conditions such as polyhydramnios (too much AF) and oligohydramnios (too little AF). Polyhydramnios and oligohydramnios are diagnosed in about 7-8% of all pregnancies and these conditions are of concern because they may lead to birth defects or to delivery complications. The amniotic fluid volume is also one of the important components of the fetal biophysical profile, a major indicator of fetal well-being.
The currently practiced and accepted method of quantitatively estimating the AF volume is from two-dimensional (2D) ultrasound images. The most commonly used measure is known as the use of the amniotic fluid index (AFI). AFI is the sum of vertical lengths of the largest AF pockets in each of the 4 quadrants. The four quadrants are defined by the umbilicus (the navel) and the linea nigra (the vertical mid-line of the abdomen). The transducer head is placed on the maternal abdomen along the longitudinal axis with the patient in the supine position. This measure was first proposed by Phelan et al (Phelan J P, Smith C V, Broussard P, Small M., “Amniotic fluid volume assessment with the four-quadrant technique at 36-42 weeks' gestation,” J Reprod Med July; 32(7): 540-2, 1987) and then recorded for a large normal population over time by Moore and Cayle (Moore T R, Cayle J E. “The amniotic fluid index in normal human pregnancy,” Am J Obstet Gynecol May; 162(5): 1168-73, 1990).
Even though the AFI measure is routinely used, studies have shown a very poor correlation of the AFI with the true AF volume (Sepulveda W, Flack N J, Fisk N M., “Direct volume measurement at midtrimester amnioinfusion in relation to ultrasonographic indexes of amniotic fluid volume,” Am J Obstet Gynecol April; 170(4): 1160-3, 1994). The correlation coefficient was found to be as low as 0.55, even for experienced sonographers. The use of vertical diameter only and the use of only one pocket in each quadrant are two reasons why the AFI is not a very good measure of AF Volume (AFV).
Some of the other methods that have been used to estimate AF volume include:
Dye dilution technique. This is an invasive method where a dye is injected into the AF during amniocentesis and the final concentration of dye is measured from a sample of AF removed after several minutes. This technique is the accepted gold standard for AF volume measurement; however, it is an invasive and cumbersome method and is not routinely used.
Subjective interpretation from ultrasound images. This technique is obviously dependent on observer experience and has not been found to be very good or consistent at diagnosing oligo- or poly-hydramnios.
Vertical length of the largest single cord-free pocket. This is an earlier variation of the AFI where the diameter of only one pocket is measured to estimate the AF volume.
Two-diameter areas of the largest AF pockets in the four quadrants. This is similar to the AFI; however, in this case, two diameters are measured instead of only one for the largest pocket. This two diameter area has been recently shown to be better than AFI or the single pocket measurement in identifying oligohydramnios (Magann E F, Perry K G Jr, Chauhan S P, Anfanger P J, Whitworth N S, Morrison J C., “The accuracy of ultrasound evaluation of amniotic fluid volume in singleton pregnancies: the effect of operator experience and ultrasound interpretative technique,” J Clin Ultrasound, June; 25(5):249-53, 1997).
The measurement of various anatomical structures using computational constructs are described, for example, in U.S. Pat. No. 6,346,124 to Geiser, et al. (Autonomous Boundary Detection System For Echocardiographic Images). Similarly, the measurement of bladder structures are covered in U.S. Pat. No. 6,213,949 to Ganguly, et al. (System For Estimating Bladder Volume) and U.S. Pat. No. 5,235,985 to McMorrow, et al., (Automatic Bladder Scanning Apparatus). The measurement of fetal head structures is described in U.S. Pat. No. 5,605,155 to Chalana, et al., (Ultrasound System For Automatically Measuring Fetal Head Size). The measurement of fetal weight is described in U.S. Pat. No. 6,375,616 to Soferman, et al. (Automatic Fetal Weight Determination).
Pertaining to ultrasound-based determination of amniotic fluid volumes, Segiv et al. (in Segiv C, Akselrod S, Tepper R., “Application of a semiautomatic boundary detection algorithm for the assessment of amniotic fluid quantity from ultrasound images.” Ultrasound Med Biol, May; 25(4): 515-26, 1999) describe a method for amniotic fluid segmentation from 2D images. However, the Segiv et al. method is interactive in nature and the identification of amniotic fluid volume is very observer dependent. Moreover, the system described is not a dedicated device for amniotic fluid volume assessment.
Grover et al. (Grover J, Mentakis E A, Ross M G, “Three-dimensional method for determination of amniotic fluid volume in intrauterine pockets.” Obstet Gynecol, December; 90(6): 1007-10, 1997) describe the use of a urinary bladder volume instrument for amniotic fluid volume measurement. The Grover et al. method makes use of the bladder volume instrument without any modifications and uses shape and other anatomical assumptions specific to the bladder that do not generalize to amniotic fluid pockets. Amniotic fluid pockets having shapes not consistent with the Grover et al. bladder model introduces analytical errors. Moreover, the bladder volume instrument does not allow for the possibility of more than one amniotic fluid pocket in one image scan. Therefore, the amniotic fluid volume measurements made by the Grover et al. system may not be correct or accurate.
None of the currently used methods for AF volume estimation are ideal. Therefore, there is a need for better, non-invasive, and easier ways to accurately measure amniotic fluid volume.